Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department

Maria Pacella

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Depression; Acute Pain

Treatments: Drug: Ketamine; Drug: Midazolam; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03436121

PRO17090065

Details and patient eligibility

About

In this proposal, the investigators will determine if a single dose of intravenous (IV) ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need for opiate analgesics both in the ED and in the acute recovery period after ED discharge. The investigators will compare the ketamine arm to an active placebo-controlled arm (with midazolam).

Full description

The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.

The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.

All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults between the ages of 18-65
2. A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale [NRS] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
3. Expected to be in the ED for at least 2 hours

Exclusion criteria

1. Non-English speaking
2. Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns)
3. Not alert and oriented
4. Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
5. Seeking treatment due to a mental health or substance use disorder
6. History of chronic opioid use
7. Prescribed opioid use within the past 24 hours
8. Any use of recreational narcotics throughout lifetime
9. Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
10. Weight > 170kg (375 lbs)
11. Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
12. Pregnancy
13. Prisoner

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Experimental Arm

Experimental group

Description:

Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam

Treatment:

Drug: Ketamine

Drug: Midazolam

Active Placebo Arm

Active Comparator group

Description:

Participants will be assigned to receive a single dose of IV placebo + midazolam

Treatment:

Drug: Placebo

Drug: Midazolam